Eighty years seems like a lifetime, and that's about how long it's been since there have been any changes to neurosurgical retraction technology, according to Vycor Medical (Bohemia, New York). The company recently broke this long standing record and reported that it launched its ViewSite Brain Access System (VBAS), a less-invasive way to access surgical locations and preform critical procedures with minimal damage to surrounding tissue.
The devices used in brain surgery now have been in existence for nearly 87 years. These metal retractors, which, according to Vycor resemble “metal nail files,“ are used by neurosurgeons to move brain tissue to enable access to the target lesions and tumors.
The tools have their drawbacks, such as brain tissue potentially causing injury or target shift, which can limit a neurosurgeon's visualization.
As a result of this, neurosurgeons have opted to forego using blade retractors during craniotiomies whenever possible. And in other cases, just the opposite happens, and surgeons are forced to use two or three retractors during the removal of deep subcortical tumors.
“Sometimes the surgeon has to use several of the metal retractors to perform the surgery,“ Heather Vinas, Vycor's president told Medical Device Daily. “And [the surgeon] still needs to have a clear channel working.“
She added that a clear view can be difficult to obtain with so many tools being used at once.
But Vycor's VBAS is said to produce less tissue trauma and allow surgeons to see the surrounding tissue during the procedure and require less retractor repositioning. The device, which resembles a glass cone has been said to lead to a speedier recovery and increase the precision of treatment, while at the same time significantly lowering the cost.
One of the reasons VBAS can cut costs is because of the material used to make the device.
“These devices are disposable and made from a polycarbon resin,“ Vinas said.
The company also said that it has an advantage in the market that other device makers don't have: the cost of its offering can be bundled as part of a procedure and will not require a separate reimbursement decision.
VBAS, which has been touted as a simple common sense solution to a complex surgery, was conceptualized back in 2005, according to Vinas.
“It was a concept that was sketched out to me on a napkin and has since transformed into a viable commercial product,“ she said.
The company first received FDA approval for VBAS in 2006, but didn't launch the device until 2009.
Vinas said that the company waited three years for the launch so it could ultimately have greater control in the commercialization and the development of the device.
“We wanted to have all of our ducks in a row,“ Vinas told MDD. “We didn't want to dump this onto big manufacturers and lose control of the commercial aspect of the device.“
Vycor also obtained approval by Health Canada in 2008 and a CE mark last year.
According to the company, the tool comes in 12 different sizes (allowing for differing shapes and sizes of the human head) and each system consists of an introducer and a working channel port that allows the surgeon an easy entry to the targeted site while distributing brain tissue evenly.
Most recently the company said that it has started the process of registering its ViewSite brain access system with China's State Food and Drug Administration (Medical Device Daily, March 18, 2010).
And Vinas said that there are even more plans underway for VBAS as the company plans to gain 70% market share with the device.
“The scope of VBAS has changed since that initial napkin sketch back in 2005, “ Vinas said. “It's now a 12-device brain access system with more products, based off the platform, to come.“
Omar Ford, 404-262-5546;